Calibration of Disintegration Apparatus (DT)

Calibration of Disintegration Apparatus (DT):

Calibration of DT includes the Sensor calibration, Strokes and Timer calibration. Details are as described below,

A. Calibration of the temperature (Sensor Calibration):

Calibration of the sensor should be performed by an external certified agency or a Highly calibrated Thermometer on below Temperature (°C),

Acceptance criteria:

Set Value	Acceptance Criteria
30°C	28-32 °C
60°C	58-62°C

B. Calibration of strokes (up/down cycle):

Calibration of stroke should be performed by setting 1 min and count the strokes. Perform the calibration Three time and take a average. Acceptance limit are as shown below,

Limits: 29-32 strokes per minute.

C. Calibration of timer:

Calibration of the Timer of DT shall be measured by means of a calibrated stopwatch. Perform the calibration Three time for each set time. Limit is described below,

Acceptance criteria:

Sr. No.	Set Time (in Min.)	Limit (For Stop Watch) (min:sec)
1	1	00:59 – 00:61
2	5	04:55 – 05:05
3	10	09:50 – 10:10
4	15	14:45 – 15:15

Calibration Frequency: The disintegration Apparatus should be calibrated yearly basis.

Cleaning of Disintegration Apparatus (DT):

• Remove water from the water bath periodically and clean the instrument and bath with clean and dry cloth.
• Use mild detergents for cleaning of the disintegration assembly

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Reference:

ICH: https://www.ich.org/

USFDA: https://www.fda.gov/regulatory-information/search-fda-guidance-documents

EMA: https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines